Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Keywords
Diabetes Mellitus, Type 2
Brief summary
This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication
Interventions
Clear, colorless, sterile solution for SC injection.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus treated with diet and/or oral agents * HbA1c 6.5-11.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the effect of pramlintide on the PK of an oral medication | 7 Days | To determine the effect of pramlintide on the pharmacokinetics of an orally administered concomitant medication (acetaminophen) when administered at various times in relation to subcutaneous (SC) pramlintide dosing. The noncompartmental plasma acetaminophen pharmacokinetic (PK) parameters used in the analyses are defined as follows: AUC(0-12hr): Area under the plasma acetaminophen concentration-time curve. Cmax : The peak acetaminophen concentrationd. Tmax : Duration from the time of acetaminophen dosing to the time of the first maximum observed concentration, Cmax. t½: Terminal half-life The primary study endpoints include: * pharmacokinetic parameters AUC(0-12 hr) and Cmax of plasma acetaminophen concentrations Secondary Study Endpoints * pharmacokinetic parameters Tmax and t1/2 of plasma acetaminophen concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability as measured by analysis of laboratory values and adverse events | 7 Days | To assess safety and tolerability of pramlintide SC injection, including adverse events, as a function of the timing of an orally administered concomitant medication (acetaminophen). |
Countries
United States
Outcome results
None listed